Quality of Life Effect of the Anti-CCR4 Monoclonal Antibody Mogamulizumab Versus Vorinostat in Patients With Cutaneous T-cell Lymphoma.

BACKGROUND: Sézary syndrome (SS) and mycosis fungoides (MF), 2 types of cutaneous T-cell lymphoma, cause significant morbidity and adversely affect patients' quality of life (QoL). The present study assessed the QoL measurement changes in patients receiving mogamulizumab versus vorinostat. PATIENTS AND METHODS: A multicenter phase III trial was conducted of patients with stage IB-IV MF/SS with ≥ 1 failed systemic therapy. The QoL measures included Skindex-29 and the Functional Assessment of Cancer Therapy-General. The symptoms, function, and QoL subdomains were longitudinally modeled using mixed models with prespecified covariates. Meaningful change thresholds (MCTs) were defined using distribution-based methods. The categorical changes by group over time and the time to clinically meaningful worsening were analyzed. RESULTS: Of the 372 randomized patients, mogamulizumab demonstrated improvement in Skindex-29 symptoms (cycles 3, 5, and 7; P < .05) and functional (cycles 3 and 5; P < .05) scales. A significantly greater proportion of mogamulizumab-treated patients improved by MCTs or more from baseline in the Skindex-29 symptoms domain (cycles 3, 5, 7, and 11) and functioning domain (cycle 5). Significant differences in the Functional Assessment of Cancer Therapy-General physical well-being (cycles 1, 3, and 5; P < .05) were observed in favor of mogamulizumab and a greater proportion of patients had declined by MCTs or more at cycles 1, 3, 5, and 7 with vorinostat treatment. The median time to symptom worsening using Skindex-29 was 27.4 months for mogamulizumab versus 6.6 months for vorinostat. In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains. The time to worsening was similar for the 2 MF treatment arms. CONCLUSION: The symptoms, function, and overall QoL of patients with MF/SS favored mogamulizumab over vorinostat across all time points. Patients with the greatest symptom burden and functional impairment derived the most QoL benefit from mogamulizumab.

Measurement of Quality of Life in Patients with Mycosis Fungoides/Sézary Syndrome Cutaneous T-Cell Lymphoma: Development of an Electronic Instrument.

BACKGROUND: Although the quality of life (QoL) plays an important role in treatment decision making and clinical management of mycosis fungoides (MF) or Sézary syndrome (SS) subtypes of cutaneous T-cell lymphomas (MF/SS-CTCLs), an MF- or SS-specific measure of QoL does not exist. OBJECTIVE: The objective of this research was to develop and validate the first QoL instrument for MF/SS-CTCL using a patient-centered approach. METHODS: A conceptual framework for the MF/SS-CTCL QoL was developed through a literature review and interviews with key opinion leaders. Concept elicitation with patients was utilized to refine the conceptual model and generate preliminary items. The items were then revised based on qualitative and quantitative feedback obtained through cognitive debriefing surveys and interviews with patients. Next, participants (N=126) completed the preliminary MF/SS-CTCL QoL and a comparator measure of health-related QoL (Skindex-29) through the PatientsLikeMe Open Research Exchange. The MF/SS-CTCL QoL was completed again 5 days later by 66 participants for the purposes of evaluating test-retest reliability. The MF/SS-CTCL QoL was finalized based on results from an empirical evaluation, which included both classical and modern test theory approaches. Specifically, this included evaluation of (1) the optimal item response theory measurement model; (2) item fit; (3) unidimensionality; (4) rating scale performance; (5) reliability; (6) test information (precision); (7) person-to-item map; (8) convergent and discriminant validity; and (9) presence of bias via differential item function. RESULTS: Results from the comprehensive psychometric evaluation utilizing a Rasch-Grouped Rating Scale model yielded a final 12-item instrument. The rating scale functioned as expected, and the instrument exhibited adequate person reliability (.87), good to excellent test-retest reliability (r=.89, P<.001), high levels of measurement precision, and good person-to-item targeting. The correlation between the MF/SS-CTCL QoL and the Skindex-29 (r=.852, P<.001) was significantly greater than the correlation between the MF/SS-CTCL QoL and syndrome stage (r=.260, P<.001), providing support for convergent and discriminant validity. Items did not show significant bias based on gender, age, or race. Rasch scores were converted to scaled scores with qualitative descriptive categories for ease of interpretation. CONCLUSIONS: Empirical evaluation demonstrated strong evidence of excellent psychometric properties. Utilizing a patient-centered measure development approach ensures that this QoL instrument captures the information that is most meaningful and clinically relevant to patients.

Health-related quality of life in patients with cutaneous T-cell lymphoma?

BACKGROUND: Little is currently known about health-related quality of life (HRQoL) of patients with cutaneous T-cell lymphoma (CTCL), a condition characterized by chronic, pruritic, visible lesions, features which may be uniquely influential. OBJECTIVE: The aim of this study was to establish baseline HRQoL data for patients with CTCL and identify its influencing factors. METHODS: Prospective, nonblinded survey design utilizing questionnaires including panels of QoL indices obtained from 105 patients with mycosis fungoides, Sezary syndrome, and CD30+ lymphoproliferative disorder. Chart review correlated QoL with year of disease onset/diagnosis, type/stage of disease, current/past therapies, and medical/psychiatric diagnoses. RESULTS: Psychiatric condition was significantly associated with symptoms (P < 0.01), emotions (P < 0.01), and functioning (P < 0.03) subscales along with overall composite measure (P < 0.01). High-grade systemic therapy (OR = 5.28) showed greater increase in odds of a lower health state than low grade (OR = 1.54). The number of medical comorbidities was significantly related to itching (P < 0.01). Increased age was a protective factor with respect to the emotions (P < 0.01), functioning (P < 0.01), and overall composite (P < 0.01) but not predictive of symptoms. Lower income was associated with higher bother on the symptoms subscale. CONCLUSIONS: HRQoL in CTCL appears related to a number of factors, including presence of a psychiatric condition, use of systemic (particularly high grade) therapy, number of medical comorbidities, and income.

Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer.

Mycosis fungoides (MF) and Sézary syndrome (SS), the major forms of cutaneous T-cell lymphoma, have unique characteristics that distinguish them from other types of non-Hodgkin's lymphomas. Clinical trials in MF/SS have suffered from a lack of standardization in evaluation, staging, assessment, end points, and response criteria. Recently defined criteria for the diagnosis of early MF, guidelines for initial evaluation, and revised staging and classification criteria for MF and SS now offer the potential for uniform staging of patients enrolled in clinical trials for MF/SS. This article presents consensus recommendations for the general conduct of clinical trials of patients with MF/SS as well as methods for standardized assessment of potential disease manifestations in skin, lymph nodes, blood, and visceral organs, and definition of end points and response criteria. These guidelines should facilitate collaboration among investigators and collation of data from sponsor-generated or investigator-initiated clinical trials involving patients with MF or SS.

Quality of life and psychological distress in patients with cutaneous lymphoma.

BACKGROUND: Cutaneous lymphomas may have a profound impact on patients' health-related quality of life (HRQoL) and psychological well-being. OBJECTIVES: To evaluate HRQoL and psychological distress in patients with cutaneous lymphoma, and to evaluate them in relation to personal and clinical characteristics. METHODS: Patients with cutaneous T-cell lymphoma or cutaneous B-cell lymphoma (CBCL) were consecutively recruited in a dermatological hospital. Data on HRQoL were collected using a dermatology-specific questionnaire, the Skindex-29, and an oncology-specific questionnaire, the EORTC QLQ-C30. RESULTS: Of 95 patients, there were 24 with CBCL, 59 with mycosis fungoides (MF) and 12 with Sézary syndrome (SS). The most frequent items reported in Skindex-29 were itching and sensitive skin, being annoyed by the disease, worry that it could get worse, affected interactions, and impairment in sexual life. The most frequent problems appearing from the EORTC QLQ-C30 analysis were fatigue, pain and insomnia. A worse HRQoL was observed for all the scales in patients with SS, followed by MF, and CBCL. HRQoL impairment in all histotypes was higher in women than in men, in patients with probable anxiety or depression, and when the disease worsened. The highest prevalence of probable anxiety or depression was observed in patients treated with systemic steroids (60%) and interferon (50%). CONCLUSIONS: The detailed evaluation of HRQoL and psychological problems in patients with cutaneous lymphomas, and their relationship with clinical variables, may give important information on the burden of the disease for patients, and thus improve communication and satisfaction with care.

Cutaneous T-cell lymphoma: overview and nursing perspectives.

Cutaneous T-cell lymphoma (CTCL) is an uncommon and complex malignancy of the immune system with a wide range of clinical presentations primarily involving the skin. An extensive menu of skin-directed and/or systemic treatment options exists. Best practices in management involve multidisciplinary collaboration. Nursing care for patients who have CTCL is a critical component in the successful management of the disease and requires special attention to the patient's physical, emotional, and spiritual needs. Nurses can make a significant impact by being accessible, offering emotional support, demonstrating advocacy, and providing ongoing education for the patient and family.